About the Company

A renowned Global company is looking for a Validation Engineer to join their Waterford site on a fixed term contract. The Engineer will be leading the validation area while engaging in process validation activities, writing protocol and validation report generation.

About your new job

• Develop Quality Change Requests (QCR’s) to introduce and validate new raw materials into existing processes.
• Organize and manage engineering projects, including scheduling time for development and validation tasks.
• Collect input from stakeholders to write protocols with clear acceptance criteria.
• Design, develop, conduct and/or review experiments to introduce alternate raw material sources while maintaining product safety.
• Conduct and support process validations.
• Carry out and assist in process validations.
• Produce reports on engineering development and validation for new materials.
• Identify through the validation process and through in process monitoring and trending, opportunities for process/productivity improvement and optimisation.
• Assist in enhancing manufacturing processes, quality, and cost efficiency.
• Support drafting new or update existing documentation such as work instructions, SOPs, pFMEA’s for process changes being introduced through validations.
• Ensure product quality and all tasks are in accordance with established SOPs, GMPs, Divisional Specifications, and EHS standards.
• Develop, design and train manufacturing personnel in required operations.
• Deliver project requirements to agreed cost, schedule, and quality requirements.
• Perform engineering analysis and implement corrective actions when issues arise.
• Collaborate with others such as Supplier Quality, Procurement to accomplish goals.
• Support the company initiatives and culture within the Company.

What skill/experience you need

• Bachelor’s degree in Science or Engineering required.
• 1+ engineering experience in high-volume manufacturing environment; Analytical Process/Product Development or Quality Engineering setting.
• Knowledge of ISO-9000,GMP, and medical device manufacturing is advantageous.
• High Volume Manufacturing experience is essential.
• Statistical analysis experience is necessary in high-volume manufacturing setting.
• Proficiency in writing and executing validation protocols in manufacturing.
• Ability to collaborate with other departments to set validation acceptance criteria, execute validations, and generate reports.
• Statistical techniques knowledge essential
• Must be able to build relationships with various internal teams and work effectively as a team member.

What’s on offer

• Fixed Term 12 Month Contract
• Excellent Rate DOE
• 24 days Annual leave
• Monday-Friday

What’s next

• Apply now by clicking “Apply Now” or contact me at 021 484 7135
• Or if the job isn’t quite right but you are looking for something similar, please get in touch.